BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO PH CAPSULE DELIVERY DEVICE

    MDR report key: 4999223 · Received August 11, 2015

    Report

    Report Number
    9710107-2015-00210
    Event Type
    Malfunction
    Date Received
    August 11, 2015
    Date of Event
    July 27, 2015
    Report Date
    August 10, 2015
    Manufacturer
    GIVEN IMAGING LTD.
    Product Code
    FFT
    PMA / PMN Number
    K102543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED BRAVO CAPSULE FAILED TO ATTACH. THERE WAS NO HARM TO THE PT OR USER.

    Description of Event or Problem · 1

    A REPEAT PROCEDURE WAS NECESSARY DUE TO THE ALLEGED DEVICE MALFUNCTION. INTERVENTION WAS NOT REQUIRED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR PROCEDURE ITSELF THAT MAY HAVE LED TO THIS EVENT. AN ENDOSCOPY WAS PERFORMED PRIOR TO THE PROCEDURE AND THE ESOPHAGUS APPEARED TO BE NORMAL. THE DEVICE OPERATOR HAS BEEN PERFORMING THIS PROCEDURE FOR OVER TEN YEARS. NO OTHER KNOWN ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524997 BRAVO PH CAPSULE DELIVERY DEVICE BRAVO FFT GIVEN IMAGING LTD. FGS-0313 28233Q

    Patients

    Seq Age Sex Outcome Treatment
    1